Foods Are Medicines: The Elusive Borderline

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Health

Legislation

" Let thy food be thy medicine and thy medicine be thy food."
Hippocrates (460-377 BC)

We might say that the debate of what is food and what is medicine goes back more than two thousand years, to Hippocrates, the Greek physician who is also known as the father of modern scientific medicine.

In the early 1960s, pharmaceutical medicines were in the headlines with a tragic development. Mothers who had taken thalidomide during pregnancy gave birth to children with severe deformities, while contraceptive pills were being sold without any controls. New pharmaceutical legislation was introduced in Europe in 1965 to prevent such disasters in the future. The European directive regulating what became known as 'medicinal specialties' defined these products in a very wide way in order to catch all possible products that should be subject to mandatory registration.

In 2004, a general overhaul of the European Union's pharmaceutical laws further extended the definition of what is to be considered a pharmaceutical medicine. According to a Commission clarification, the extension was necessary to cover new types of drugs being developed. Gene therapy, radiopharmaceutical products and certain medicinal products for topical use are specifically mentioned. The document is at pains to allay fears that the further extension of the definition of a medicine could be used to remove existing health products from the market. It is argued that only in cases of doubt would the provisions of the new pharmaceutical laws be applied to products that might also be fitting in other categories.

While this sounds reasonable, it is fraught with grave uncertainties for both producers and consumers of supplements. The devil is clearly in the details here, because it is that whole category of borderline products which this new definition seeks to eliminate, that's in danger of vanishing. These products are perhaps the most sought-after of the natural remedies but I doubt the Commission officials or the politicians who passed the law have come to realize the extent of the problem yet.

A series of pending legal cases before the European Court of Justice might give us more of an idea of what we are talking about. These cases are against the German health authorities and regard their refusal to acknowledge that certain products are food supplements and should be freely on sale there.

The products subject to these cases are

- a probiotic product supplying several strains of diverse lactobacillus-type cultures

- a 1000 mg vitamin C with bioflavonoids

- a product with oligomeric procyanidins - flavonol extract

- a buffered C product with 1000 mg vitamin C and 110 mg of calcium - providing calcium ascorbate

- a 400 IU vitamin E product in tablet form.

While most people who consume or otherwise have to do with natural products would agree that these products are indeed supplements, the question seems to be looked at quite differently by national health authorities, at least by the Germans (who stopped importation) and by Spain and Sweden (who filed pleadings arguing in favour of the Germans' viewpoint).

These are the most salient impressions I got when reading the papers.

1) Both the Commission and the member states seem quite serious that there will be no more "grey area" products. After passage of the food supplements directive and the amendments to the pharmaceutical directive, all products on the market will be forced into either one or the other of two categories: a food - or a medicine.

2) The Commission is exceedingly cautious in its approach to this question, recommending that the EU court should not decide on the merits of where to collocate individual products, saying this is for the national health authorities and for the national courts to decide. I take this as a sign of acknowledging that supplements are an exceedingly hot potato politically, and that - although the Commission did everything in its power to usher the new directives on supplements and pharmaceutical medicines through the parliamentary approval process, it now wants to leave the "dirty work" (of deciding what supplements to take off the market) to the national health authorities and the national courts.

3) The Commission also argues that the European Food Safety Agency should not make such a decision either, nor supply any "expert opinion" to the national (German, in this case) court for guidance. This can only reinforce the impression that the Commission does not want to be caught in the middle of a fight between natural health stakeholders and the more restrictive EU member states.

4) After reading all three opinions, it seems to me that they may have been co-ordinated in some way, (perhaps by the Commission itself or by the Germans asking their colleagues from other countries to "give them a hand"). Although there are some differences of views, there are remarkable similarities in the three sets of arguments, especially in the precedents they all refer to.

5) The Spanish Abogado del Estado states quite clearly that all the products in question, in Spain's view, are certainly medicines, but concedes that such national views are not necessarily binding on other member states, where the same products may be considered foods and be sold as supplements. Spain does seem to see a slight problem in this diverse classification but the only recommendation is to streamline the medicinal registration procedures so as to speed up market access for products that may have been taken off as "unregistered medicines".

6) The Swedish government, through the legal secretariat of its Foreign Ministry, does not pronounce an opinion on the products as such and in this aspect argues in a similar way as the Commission, in the sense that it is up to national authorities and courts to decide. The Swedes however do see a problem with differing national interpretations and would like to see common criteria for decision making to be established at the EU level, for what constitutes a medicine and what instead is a food supplement.

7) All the intervening parties, including the Commission, agree that any product that is intended or may be used to "make a medical diagnosis or to correct, improve or influence human physiological functions", (re-translated from German, English wording not perfectly identical to the pharmaceutical directive) are to be seen as medicines and thus must be registered as such. They also agree, that in case of doubt the pharmaceutical interpretation must have precedence.

What does all this mean for us?

First, it brings us to the realization that indeed the food supplements directive, but even more so the pharmaceutical directive will potentially lead to the medicalization of a large number of useful supplements - all those that do more than merely "correct deficiencies in the normal food intake".

It also shows that the directives on health products do not fulfull their primary purpose, that of harmonizing the laws of the member countries, with regard to health products. In fact, the situation seems to be quite the same as before the directives: National authorities and courts can and, according to the EU Commission, are actually expected to autonomously decide what is and what isn't a medicine. It is freely acknowledged that there will be differences in interpretation. Barriers to trade inside the EU will likely persist.

No one addresses another question that is prominent, at least in the back of my mind: In case a product gets declared a medicine by national authorities and someone does make an application to register it as a medicine, what happens if that medicine registration is turned down because the applicant could not show efficacy in treating or preventing a disease. Does the product then revert to being considered a supplement, or is it irretrievably lost in the maze of regulatory red tape? I rather suspect the latter.

The Alliance for Natural Health is arguing in their present case before the European Court that there should be no prohibition of sale for products that do not adhere to the narrow prescriptions of the food supplements directive. But the question of medicinal interpretation taking precedence in cases of doubt per the EU's new medicines definition seems to be even more important and potentially more disastrous for the future of food supplements in Europe.

Searching for a solution to the problem, Julia in the UK comments:

... if only supplements that 'correct deficiencies' might be permitted we need to develop stronger arguments along the line that if a supplement can be shown to have a benefit, it must by definition be evidence of a deficiency. i.e if a food can produce a benefit, it is evidence of a deficiency, rather than if a food can produce a benefit it must be a medicine.

To this, Tamara in Denmark replies:

Interesting argumentation! However, with the new definition of medicinal products according to the EU Directive 2004/27/EC, which (as you well know) states that any substance "... correcting ... physiological functions ..." will be defined as a medicinal product, I am not so sure this can be used either.

Examining the problem

My own thoughts trying to focalize the problem so a solution can be found, were sent to both, but I think some readers of this site might also be interested.